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DOV drops ocinaplon

This article was originally published in Pharmaceutical Approvals Monthly

15 Nov 2005

News

Executive Summary

DOV is discontinuing development of its GABA receptor agonist ocinaplon "due to an unacceptable rate of liver enzyme elevations," the firm says Oct. 28. Ocinaplon, which had been in development for generalized anxiety disorder, had experienced several clinical holds, the most recent occurring in August (1Pharmaceutical Approvals Monthly September 2005, p. 15). "DOV will select a follow-on candidate from one of the backup compounds in its preclinical program," the company says. The firm also confirmed plans to submit an NDA for use of its non-opioid analgesic bicifadine in chronic low back pain during the first half of 2007. Phase II studies in osteoarthritis and neuropathic pain are slated to begin in the fourth quarter of 2005; an acute pain sNDA is slated for the fourth quarter of 2007...